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BMS’ Camzyos fails in Phase III non-obstructive hypertrophic cardiomyopathy trial
Bristol Myers Squibb (BMS) has announced that its Phase III ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its co-primary endpoints. The study, which enrolled 580 adults with symptomatic nHCM, showed no significant difference between Camzyos and placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) or peak oxygen consumption (pVO2) after 48 weeks. Secondary endpoint results have not yet been disclosed. While disappointing for BMS, which was pursuing a label expansion, these findings do not impact Camzyos' established safety and efficacy in obstructive HCM. Approved by the FDA in 2022 for obstructive HCM and in Europe in 2023, Camzyos remains the only FDA-approved therapy for that form. BMS faces upcoming competition from Cytokinetics, whose aficamten is under FDA review. Investigators suggest that the differing outcomes reinforce the need to consider obstructive and non-obstructive HCM as distinct clinical entities.
23-04-2025